DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

Drug Registration Guidance Document (DRGD)NO.SPECIFIC LABELLING REQUIREMENTS (SUBSTANCE SPECIFIC)121. ROPIRINOLEPlease refer to DOPAMINERGIC INGREDIENT122. ROSIGLITAZONE122.1 The following black boxed warning shall be included in the packageinserts of products containing Rosiglitazone as single ingredient or incombination with other active ingredients :Rosiglitazone is contraindicated in patients with established NYHAClass I to IV heart failure and in patients with known ischaemicheart disease, particularly in those taking nitrates.Thiazolidinediones, including rosiglitazone, cause or exacerbatecongestive heart failure in some patients. Patients on rosiglitazoneshould be monitored carefully for signs and symptoms of heartfailure (including excessive, rapid weight gain, dyspnea, and/oredema). If these signs and symptoms develop, the heart failureshould be managed according to current standards of care.Furthermore, discontinuation or dose reduction of rosiglitazonemust be considered.122.2 The following information shall be included in the package inserts ofproducts containing Rosiglitazone as single ingredient or in combinationwith other active ingredients :CONTRAINDICATIONSRosiglitazone is contraindicated in patients with NYHA Class I to IVheart failure or history of cardiac failure, patients with known ischaemicheart disease and patients with Acute Coronary Syndrome (unstableangina, non-ST segment elevation myocardial infarction (NSTEMI) andST segment elevation myocardial infarction.WARNING & PRECAUTIONSRosiglitazone has been shown to be associated with an increased riskof myocardial ischaemia (angina, infarction) in pooled short term clinicalstudies compared to combined active/placebo control ( 2.00% versus1.53%). Death from myocardial ischaemic events occurred in 0.15% onrosiglitazone – containing regimens and 0.12% on comparator regimen.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 411